# K202003: Nitrile Powder Free Examination Glove, Blue Tested for Use with 32 Chemotherapy Drugs and Fentanyl Permeation Resistance Claim

- Pathway: 510(k) (Traditional)
- Applicant: Gmp Medicare Sdn. Bhd.
- Decided: Feb 24, 2021 after 219 days
- Product code: LZA (Polymer Patient Examination Glove)
- Device class: 1
- Regulation: 21 CFR 880.6250
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K260312: Nitrile Powder Free Examination Glove, Blue Tested for Use with 32 Chemotherapy Drugs and Fentanyl Permeation Resistance Claim; Nitrile Powder Free Examination Glove, Violet Blue Tested for Use with 32 Chemotherapy Drugs, Xylazine, Fentanyl & Gastric Acid (2026), 0 descendants of its own

## Indications for use
A patient examination glove is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. This glove was tested for use with chemotherapy drugs and Fentanyl Citrate as pet ASTM D6978-05 (Reapproved 2013), Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.

Source page: https://510kreport.com/device/K202003
Methodology: https://510kreport.com/methodology